Status:
TERMINATED
Treatment Satisfaction of Insulin Glargine Plus Insulin Apidra Compared With NPH Insulin Plus Insulin Apidra in Recently Diagnosed Type 1 Diabetes Children and Adolescents
Lead Sponsor:
Rabin Medical Center
Collaborating Sponsors:
Sanofi
Conditions:
Diabetes Type 1
Eligibility:
All Genders
7-20 years
Phase:
NA
Brief Summary
A randomized, crossover, open study in order to compare treatment satisfaction with insulin Glargine plus insulin Apidra Vs NPH insulin plus insulin Apidra in newly diagnosed children and adolescents ...
Detailed Description
A randomized, crossover, open study in order to compare treatment satisfaction with insulin Glargine plus insulin Apidra Vs NPH insulin plus insulin Apidra in newly diagnosed children and adolescents ...
Eligibility Criteria
Inclusion
- Type 1 diabetes diagnosed less than 12 months prior to study entry
- Age: 7-20 years old.
- HbA1c\>/=8.0
- Signing inform consent form
Exclusion
- Any significant disease or conditions, including psychiatric disorders that in the opinion of the investigator are likely to effect his compliance or ability to complete the study.
- Patients participating in other device or drug studies.
- Any contraindication to insulin glargine and or insulin Apidra and or Insulin NPH according to SmPC.
- Inability, of adolescent or parent, to understand/complete the Treatment satisfaction questionnaire.
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2012
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT00925977
Start Date
July 1 2009
End Date
February 1 2012
Last Update
June 5 2012
Active Locations (4)
Enter a location and click search to find clinical trials sorted by distance.
1
Soroka hospital
Bear Sheva, Israel
2
Rambam Hospital
Haifa, Israel
3
Health care unit- Jerusalem
Jerusalem, Israel
4
Schnider children medical center
Petah Tikva, Israel